Stressed Testing: Challenges with Medical Device Testing

COVID-19 created exceptional demand for medical device testing in 2020 and this trend will continue throughout 2021. Much of the investigative and R&D work conducted by medical device manufacturers (MDMs) ceased during the first half of 2020, but is starting to return now that the industry has learned how to operate during the pandemic. Due to lost time last year, there is a big rush on testing services and timelines will have to be extended in most cases.

“Many of the postponed projects have picked back up and the industry is trying to accelerate and get back on track,” said Maciej Jakucki, medical device testing manager for Element Materials Technology, a Cincinnati, Ohio-based provider of testing services for medical, pharmaceutical, and diagnostic devices. “The last three months in the medical space have been as busy as we have ever seen it.”

The impact of COVID-19 has been massive. Laboratory work cannot be done remotely. Even with personal protective equipment (PPE), laboratory staff are handling carcinogens, mutagens, toxins, and sensitizers. Many procedures require lab staff to be in close contac